Phase 3 N=2,370 Treatment

Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)

Chronic Idiopathic Constipation

Bottom Line

View on ClinicalTrials.gov: NCT01919697 ↗

Enrolled (actual)

2,370

Serious AEs

1.7%

Results posted

Jul 2019

Primary outcome: Primary: Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) — 123; 620 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Plecanatide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bausch Health Americas, Inc.
Primary completion: Jan 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE)	123; 620	—
PRIMARY Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide	14; 111	—
PRIMARY Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg)	121; 122.9; 75.7; 76.5	—
PRIMARY Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute)	71.2; 71.9	—
PRIMARY Summary of Vital Signs at >Day 364 - Body Temperature (°C)	36.62; 36.59	—
PRIMARY Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute)	15.7; 16.0	—
PRIMARY Summary of ECG Results Shift From Baseline at > Day 364	27; 42; 15; 44	—
PRIMARY Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline	192; 1498	—
SECONDARY Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364	1.8; 1.7	—
SECONDARY Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364	1.8; 1.7	—
SECONDARY Summary of Patient Global Assessment (PGA) for Treatment Satisfaction at > Day 364	4.1; 4.2	—
SECONDARY Summary of Patient Global Assessment (PGA) for Treatment Continuation at End of Treatment	4.1; 4.1	—

Summary

This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).

Eligibility Criteria

Inclusion Criteria

Patient completed a previous double-blind plecanatide study and was compliant with the study requirements.
Patient is in good health without unstable acute illness or exacerbation of an unstable chronic illness or chronic disease that may affect study assessments, particularly if there has been a significant change to health status since the previous plecanatide study.

Exclusion Criteria

Patient has had major surgery including laparoscopic procedures requiring general anesthesia within 60 days of Day 1.
Patient has a medical history of hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
Patient has taken a protocol-prohibited drug without the appropriate washout period.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01919697). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.